Spinery RF Ablation System
K-Number: K223303 · 2023-08-30
ApplicantAxon Spine Medical System
Decision Date2023-08-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Spinery RF Ablation System is a medical device manufactured by Axon Spine Medical System. It received FDA 510(k) clearance on 2023-08-30 under approval number K223303. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Spinery RF Ablation System?
Spinery RF Ablation System is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Axon Spine Medical System. The 510(k) number is K223303.
When was Spinery RF Ablation System approved by the FDA?
Spinery RF Ablation System received FDA 510(k) clearance on 2023-08-30, under approval number K223303.
What company makes Spinery RF Ablation System?
Spinery RF Ablation System is manufactured by Axon Spine Medical System.
What is the FDA product code for Spinery RF Ablation System?
The FDA product code for Spinery RF Ablation System is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.